A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Consistency of bladder volumes
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Having a full bladder may improve the effectiveness of radiation therapy to the bladder. It is not yet known which set of bladder-filling instructions is more effective in helping patients keep their bladder full during radiation therapy.
PURPOSE: This randomized clinical trial is comparing two sets of bladder-filling instructions in treating patients with prostate cancer undergoing radiation therapy.
详细描述
OBJECTIVES:
Primary
- To compare the consistency in bladder volumes in patients with prostate cancer undergoing conformal radiotherapy, when randomized to one of two sets of bladder-filling instructions.
Secondary
- To compare the incidence of acute and late genitourinary and gastrointestinal toxicity in patients treated with these methods.
- To determine patient satisfaction with the bladder-filling instructions.
- To determine satisfaction of bladder-filling protocols amongst radiation therapists and doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of prostate cancer
- •Undergoing a radical course of radiotherapy
- •Planned treatment in the supine position
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •No history of urinary incontinence or urinary catheterization
- •No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/medical team that the patient may not be able to comply with the protocol
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No previous surgery for urinary conditions, except transurethral resection of the prostate (TURP)
- •Prior transrectal ultrasound (TRUS) allowed
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients empty their bladders and consume 3 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a BVI periodically during treatment.
干预措施: pre-procedural preparation (Procedure)
Arm I
Patients empty their bladders and consume 6 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a bladder volume instrument (BVI) periodically during treatment.
干预措施: pre-procedural preparation (Procedure)
结局指标
主要结局
Consistency of bladder volumes
时间窗: 2011
次要结局
- Incidence of acute and late genitourinary and gastrointestinal toxicity(4 years)
- Patient satisfaction with bladder-filling instructions(2011)
- Staff satisfaction of bladder-filling protocols(2011)